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Safety and Tolerability of AZP-3813, a Growth Hormone Antagonist, in Healthy Adults for Treatment of Acromegaly

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What is this trial about?

A plain-language summary of the goals, design and what participants do

The study focuses on Acromegaly, a rare condition in which the body makes too much growth hormone, leading to enlarged hands, feet, and facial features. The investigational medicine being tested is called AZP-3813, which works as a growth hormone antagonist to block the effects of excess hormone. The drug is given as a subcutaneous injection, meaning it is administered just under the skin, and a matching placebo is used for comparison.

The main purpose of the trial is to assess how safe the medication is and how well people tolerate it, while also measuring how the drug moves through the body (pharmacokinetics) and how it affects the body’s hormone activity (pharmacodynamics). One of the hormone markers that will be checked is IGF-1, a protein that usually rises when growth hormone levels are high.

Participants will first receive a single dose of the study drug or placebo, followed by a series of doses given once daily for two weeks. Throughout the study, regular check‑ups will record any side effects, vital signs, and basic lab tests, and blood samples will be taken to track the drug’s levels and hormone changes.

The research process

The trial runs in 8 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Baseline Assessments

    You will undergo a series of baseline tests after joining the study. These include blood sampling to measure laboratory values, a physical examination, measurement of vital signs such as blood pressure and heart rate, and a 12‑lead ECG to record heart activity. The purpose is to establish your health status before any medication is given.

  2. Step 2

    Single Dose Administration

    You will receive one subcutaneous injection (injection under the skin) of the study medication azp-3813 or a matching placebo. The active dose is either 90 mg or 120 mg, prepared as a powder that is dissolved for injection. The injection is given once at a single visit.

  3. Step 3

    Short‑Term Monitoring After Single Dose

    Following the injection, you will stay in the clinic for several hours while staff check your vital signs, observe the injection site, and collect blood samples at multiple time points (for example, immediately before the dose and at 1, 2, 4, 8, and 24 hours after the dose). These samples help assess how the drug is absorbed and cleared from your body.

  4. Step 4

    Washout Period

    A short break of several days will follow the single‑dose phase. This washout period allows the drug to leave your system before the next phase of the study begins.

  5. Step 5

    Multiple Dose Phase

    You will receive a subcutaneous injection of the same dose (90 mg or 120 mg) of azp-3813 once daily for 14 consecutive days. Each injection is administered in the same manner as the single dose.

  6. Step 6

    Ongoing Monitoring During Multiple Doses

    During the 2‑week dosing period, you will attend regular clinic visits. At each visit, staff will check your vital signs, examine the injection site, and perform ECG recordings. Blood samples will be taken periodically to measure drug levels, laboratory safety parameters, and serum IGF‑1 (a hormone related to growth).

  7. Step 7

    End‑of‑Study Assessments

    After the final injection on day 14, you will undergo a final set of assessments similar to the baseline visit. This includes blood tests, vital‑sign measurements, ECG, and a physical examination to document any changes that occurred during the study.

  8. Step 8

    Follow‑Up Safety Check

    A few days after the end‑of‑study visit, you will be contacted for a brief safety follow‑up. This may involve a short phone call or an additional clinic visit to ensure that no delayed side effects have appeared.

Who can join the trial?

12 criteria

  • Be a male or female who cannot become pregnant (nonchildbearing potential: unable to get pregnant because of surgery, menopause, or other reasons).
  • Agree to avoid alcohol for 48 hours (2 days) before screening and admission, and avoid grapefruit juice for 72 hours (3 days) before the first dose of the study drug.
  • Be in good physical and mental health, confirmed by medical history, a physical exam, laboratory tests, a 12‑lead ECG (a heart test), and vital‑sign measurements.
  • Be willing and able to sign the informed consent form (ICF: a document that explains the study and your rights).
  • Be between 18 and 65 years old at the time of screening.
  • Have a body‑mass‑index (BMI) from 19.0 to 28.0 kg/m² (BMI is a measure that relates weight to height).
  • Weigh at least 50 kg at screening.
  • If female, have a negative serum pregnancy test at screening and admission and meet the criteria for nonchildbearing potential (e.g., surgically sterilized, or at least 1 year post‑menopause with no periods for 12 months).
  • If male and not surgically sterilized, agree to use adequate contraception from admission until 90 days after the last study visit (methods include a condom plus a hormonal method or intrauterine device used by a partner who can become pregnant, or condom alone if the partner cannot become pregnant).
  • If male, agree not to donate sperm from admission until 90 days after the last study visit.
  • Stop all prescribed medicines at least 14 days before admission, as decided by the investigator.
  • Stop all over‑the‑counter medicines, vitamins, supplements, and herbal products (e.g., St. John’s Wort) at least 14 days before admission, except paracetamol, which may be taken up to admission.

Who cannot join the trial?

14 criteria

  • Have taken part in this study before.
  • Have taken another experimental drug within the last 30 days or within a time equal to five times that drug’s half‑life (the time it takes for half of the drug to leave the body), whichever is longer; also have taken part in four or more other drug studies in the past year.
  • Have given or lost more than 450 mL of blood in the 60 days before the first dose, or have given or lost more than 1.5 L of blood (if male) or more than 1.0 L of blood (if female) in the past 10 months.
  • Have had a serious or sudden illness in the 5 days before the first dose that could affect safety tests, according to the study doctor.
  • Have veins that are not suitable for giving an injection or taking blood samples.
  • Plan to receive a COVID‑19 (SARS‑CoV‑2) vaccine between two weeks before coming to the clinic and the day you leave.
  • Work for the study sponsor or for ICON (the research organization).
  • Have mental incapacity, are unwilling, or have language problems that prevent understanding or cooperating with the study.
  • Have known allergies to the study drug or to foods or medicines that are chemically similar to the study drug, which is a GH antagonist (a medicine that blocks growth‑hormone action).
  • Have used tobacco products (like cigarettes, cigars, or vaping) within the three months before the first dose.
  • Have a history of alcohol abuse or drug addiction (including cannabis) within the past two years.
  • Test positive for illegal drugs or alcohol at the screening visit (the test looks for opiates, methadone, cocaine, amphetamines, ecstasy, cannabinoids, barbiturates, benzodiazepines, certain antidepressants, nicotine, and alcohol).
  • Usually drink more than 24 units of alcohol each week (one unit is about 250 mL of beer, 100 mL of wine, or 35 mL of spirits).
  • Test positive for infections such as hepatitis B surface antigen (HBsAg), hepatitis C antibodies (HCV), or HIV‑1/2 antibodies.
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Investigated drugs

AZP-3813 is an experimental drug that blocks the action of growth hormone. In this study it is given as a powder that is mixed with liquid and injected just under the skin. The purpose of using AZP‑3813 is to see if it is safe and well‑tolerated in healthy people, and to learn how the body absorbs, distributes, and clears the drug, as well as how it affects growth‑hormone activity.

What is already known about the treatment

AZP-3813 - AZP-3813 is given as a powder that is mixed with liquid and injected under the skin (subcutaneous injection). It is an experimental drug still in early clinical testing and not yet approved for any medical use. The medication is being studied for treating acromegaly, a condition caused by excess growth hormone, by blocking the hormone’s receptor and preventing its effects. It belongs to the class of growth‑hormone receptor antagonists.

Investigated diseases

Acromegaly - Acromegaly is a hormonal disorder caused by excess growth hormone, most often from a pituitary tumor. It leads to gradual enlargement of bones and soft tissues, especially in the hands, feet, and face. Over time, the skin becomes thicker, joints may stiffen, and internal organs can increase in size. The condition develops slowly over many years, with symptoms becoming more noticeable as the hormone excess continues.
Trial detailsLast updated 15 Nov 2026
Age18+ yearsPhasePhase ITrial ID2023-503734-47-00Protocol codeAZP-3813-CLI-001Estimated enrolment101 patientsSponsorAmolyt Pharma

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